NCT06609434Not yet recruiting
The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer
The Role and Safety of Radiofrequency Ablation in the Multidisciplinary Treatment of Intrahepatic Recurrence After Colorectal Cancer Liver Metastasis Surgery
Source: ClinicalTrials.gov · Last updated 27 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to learn if radiofrequency ablation works to treat recurrent colorectal cancer liver metastases after surgery in adults. It will also learn about the safety of radiofrequency ablation. The main questions it aims to answer are: Is radiofrequency ablation safe and effective in the treatment of recurrent colorectal cancer liver metastases? What medical problems do participants have when treating with radiofrequency ablation? Does radiofrequency ablation enable patients with recurrent colorectal cancer liver metastases to live longer? Researchers will compare systemic therapy combined with radiofrequency ablation to systemic therapy to see if radiofrequency ablation works to treat liver metastases better. Participants will: Receive systemic treatment for colorectal cancer liver metastases. Undergo (or not) radiofrequency ablation for colorectal cancer liver metastases. Visit the hospital once every 3 months for checkups and tests.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 111 (estimated)
- First submitted
- 21 Sept 2024
- Start date
- Oct 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT06609434
What you commit to
- Study type: Interventional
- Planned participants: 111
- From Oct 2024 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Body temperature \>101°F (38.3°C) immediately prior to study treatment;
- Being treated with other investigational drugs;
Other illness
- Suffering from, but not limited to, the following serious illnesses: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening cardiac arrhythmia within the last 6 months;
- Known hypersensitivity to any of the intravenous imaging agents that will be used in the study;
- Have portal or hepatic vein tumor infiltration/cancer embolism;
- Heart failure NYHA functional class III or IV.
Lab values
- Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test prior to receiving study treatment;
- Platelet count \<50, 000/mm3, absolute neutrophil count \<1500/mm3, or hemoglobin value \<10.0 g/dL;
- Serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤ 25.0 ml/min;
- Serum bilirubin \>3.0 mg/dL;
- Serum albumin \<2.8 g/dL;
Other
- Prothrombinogen international normalized ratio \>1.5 times the upper limit of normal (UNL) at the study center;
- Any other circumstances that the investigator deems inappropriate for enrollment.
Who the study is looking for
- Patients with colorectal cancer whose primary lesions have been resected or can be controlled;
- Multiple confined lesions in the liver, the number of which can be defined;
- The liver contains at least 2 lesions suitable for radiofrequency ablation;
- The maximum diameter of the intrahepatic tumor is \<5 cm;
- The location of the hepatic lesion does not show obvious invasion with neighboring organs or large blood vessels;
- No extrahepatic metastases or stable extrahepatic metastases;
- Re-operative hepatic surgical resection is not indicated or refused;
- Ultrasound or ultrasonography can show intrahepatic lesions;
- The patient and his/her family request active treatment;
- Voluntary informed consent;
- Male or female at least 18 years of age;
- Platelet count \>50, 000/mm3 and prothrombin activity \>50%;
- Subjects are willing to return to the study center for study follow-up;
- Life expectancy ≥ 6 months.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.